'Rough notes' and backdated signatures land Indian API maker US FDA warning

Gujarat, India-based Mahendra Chemicals slammed with US FDA warning letter

Issues with batch production records at an Indian facility have landed API maker Mahendra Chemicals with a US FDA warning letter.

FDA offers draft guidance on quality metrics used to assess drug manufacturing

FDA offers draft guidance on quality metrics used to assess drug manufacturing

Protein PEGylation example, c/o celares

EMD Millipore and celares team to offer PEGylation to biologic makers

For the first time in six years, the Senate Committee completed all 12 appropriations bills. (Image: Senate.gov)

Senate Committee OK’s extra $40m to FDA but refuses Obama’s $146m plan

Hikma buys B-I generics subsidiary, strengthens position in US market

Hikma buys B-I generics subsidiary, strengthens position in US market

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Regulatory & Safety

People on the Move in pharma

Senior changes at Sanofi-Merck JV, Novo Nordisk, ABPI, and MedImmune

EU and Swiss agencies strengthen ties with confidentiality agreement

EU and Swiss regulators strengthen ties with confidentiality agreement

FreightWatch: GPS a must for trucks carrying pharma cargo

Drugs stolen while trucker changed his clothes recovered thanks to hidden GPS

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Ingredients

Less than a year for excipient risk assessments

Less than a year to risk assess excipients: IPEC Europe develops 'how to' guide

Lonza argues that its global hedge is starting to bare fruit

Lonza: global hedge helped offset currency exposure but Visp still a risk

Johnson Matthey’s API business flat in Q1 on timing of opiate API orders

Johnson Matthey’s API business flat in Q1 on timing of opiate API orders

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Drug Delivery

The facility in Ediburgh, Scotland was acquired when Capsugel bought Encap in 2013

Capsugel expanding Encap plant on rising HPAPI demand

West's Scottsdale facility in Arizona

West scaling up AZ plant on demand for Smartdose wearable injector

NASA used unmanned plane to fly drugs 50km - safety pilot was present but a ground team was in control

Planes, drones but no automobiles: NASA pilots pilotless plane for drug delivery

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Processing

US FDA finalises analytical procedures and methods validation guidance

US FDA finalises analytical procedures and methods validation guidance

Teva has struck a mega-deal to buy Allergan's generics wing, after months of pusuing Mylan,

Teva to buy Allergan's generics biz for $40.5bn

Sandoz head Richard Francis spoke during an earnings call this week. (Image: Sandoz/YouTube)

Sandoz shutters German and Indian production sites

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Popular News

Sandoz head Richard Francis spoke during an earnings call this week. (Image: Sandoz/YouTube)

Sandoz shutters German and Indian production sites

US FDA bans imports manufactured at Emcure’s Indian plant

US FDA bans imports manufactured at Emcure’s Indian plant

Teva has struck a mega-deal to buy Allergan's generics wing, after months of pusuing Mylan,

Teva to buy Allergan's generics biz for $40.5bn

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